Associate Director External Manufacturing Quality biologic

Contract Type: Permanent
Location: HOME BASED
Contact Email: gerry@rftgroup.ie

Job Description

Associate Director, External Manufacturing Quality Biologics / Steriles

Our client enjoys a strong reputation as a company that is highly respected, a sought-after place to work where career development and advancement is enabled in a positive, patient focussed, collaborative environment. This highly ambitious, fast growing multinational biopharmaceutical company has an exciting pipeline of innovative drug compounds at an advanced stage in research.

Job Spec:

Quality assurance Product quality lead for company sterile/ Biotech products within the external manufacturing network, which oversees contract manufacturing operations, select supply chain operations and development functions as well as Internal Quality Systems.Reports directly to the Senior Director Quality Assurance and acts as deputy where when required
  • This position is responsible for leading the oversight of the quality performance of contract manufacturers, distributors, and material suppliers to all applicable standards for GMP and GDP.
  • The individual is responsible for, but is not limited to:
    • Leading and Managing product quality related priorities and tasks at the respective contract manufacturers (Biologics / Sterile contract manufacturers).
    • Perform the role of Quality assurance lead withing specific commercial product teams.
    • Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and release, reviewing and approving product complaints, deviations, change controls and leading product related investigations
    • Designing, Implementing, and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time and leading training
    • Facilitating technology transfer, process scale-up and process improvement protects
    • Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Quality Technical Agreements (QTAs)
    • Assisting in internal audits and regulatory agency inspections
Essential Functions
  • This position is responsible for leading the oversight of the quality performance of contract manufacturers, distributors, and material suppliers to all applicable standards for GMP and GDP. This individual will receive assignments in the form of goals.
  • The individual is responsible for, but is not limited to:
    • Leading and Managing product quality related priorities and tasks at the respective contract manufacturers (Biologics / Sterile contract manufacturers)
    • Perform the role of Quality assurance lead withing specific commercial product teams.
    • Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and release, reviewing and approving product complaints, deviations, change controls and leading product related investigations
    • Designing, Implementing, and improving quality systems to realize the highest quality standards attainable for all activities conducted by the company, supporting Product Quality Review and annual report completion on time and leading training
    • Facilitating technology transfer, process scale-up and process improvement protects
    • Building authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Quality Technical Agreements (QTAs)
    • Assisting in internal audits and regulatory agency inspections
    • Ensure compliance of all respective contract manufacturers to both internal requirements and country specific regulations
    • Highlight any risks associated with maintaining supply of commercial drug products to all markets and offer innovative and effective ways to minimize such risks
    • Anticipates internal and/or external business challenges and/or regulatory issues and leads any associated remediation activities.
  • Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets
Person Spec
  • Highly organised, with exceptional time management and prioritisation
  • Critical thinking and evaluation of complex process and product problems
  • Excellent verbal and written communication skills
  • Patient and results focused
  • Good Leader and highly motivated.
  • Proven Ability to manage divergent views
  • Collaborative team player
  • Strong work ethic with a flexible and adaptable approach
  • Proven ability to Solve unique and complex problems that have a broad impact on External manufacturing QA and/or associated product teams
  • Contributes to the development of functional and/or broader department strategy
  • Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline
  • Significant experience (10 years minimum) working in finished product pharmaceutical / biologics, including validation, analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
  • Thorough understanding of Quality Systems and cGMP’s.
  • Experience with third party vendor auditing, out of spec investigations, change control
  • Experience working with contract manufacturing
  • Quality Risk Management Experience essential
  • Eligible to be a Qualified person
  • Experience interfacing with regulatory bodies or working on regulatory submissions
Biologics drug substance / Drug Product experience is essential for this role

cv to gerry@rftgroup.ie